TEHRAN: The U.S. Department of the Treasury, Office of Foreign Assets Control (OFAC), on December 22, 2016 announced amendments to the general license (GL) that authorizes the export or re-export of certain medical devices to Iran. With these amendments, OFAC has substantially expanded the scope of medical devices generally authorized for export or re-export to Iran without the need for a specific license.
These changes — which also include new or expanded authorizations related to training, replacement parts, software and services for the operation, maintenance and repair of medical devices — went into effect on December 23, 2016.
According to details, although the GL authorizes a wider spectrum of activities without the need to apply to OFAC for a specific license, a number of important limitations and restrictions remain, including more generally with respect to dealings involving Iran for which the United States retains an embargo. It therefore remains crucial to maintain a robust sanctions compliance policy, including thorough counterparty and product due diligence, to determine whether a particular transaction is indeed covered by the GL. Affected parties may want to review their compliance policy and related training programs in light of this revised framework for medical devices.
It is important to note, however, that even under the amended GL, certain restrictions remain in place. For example, as under the prior GL, all medical devices exported or re-exported under the GL must be shipped within a 12-month period beginning on the date of the contract for export or re-export, and the transactions must meet specific financing and payment terms. Additionally, the GL does not authorize (i) the exportation or re-exportation of medical devices to military, intelligence or law enforcement purchasers or importers, or (ii) otherwise proscribed conduct, such as the involvement of individuals or entities on OFAC’s List of Specially Designated Nationals and Blocked Persons.
Exporters to Iran and those that process or support the transactions must also bear in mind that, as with the prior version of the GL, the amended GL only authorizes exports or re-exports by “covered persons.”
